Hetero Labs seeks nod for emergency use from India for Molnupiravir’s Covid-19 drug

Hyderabad: The use of Molnupiravir, an experimental oral drug having antiviral properties, has resulted in early recovery of COVID patients with mild symptoms when compared to standard treatment, during Phase 3 clinical trials, Hetero said on Friday citing interim data.

The city-based drug maker also said it has approached the Drug Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for Molnupiravir in India.

Hetero had commenced a phase-III, comparative, randomized, multicenter clinical trial on mild Covid-19 patients.

These clinical trials were aimed at evaluating the efficacy and safety of Molnupiravir plus standard of care (test arm) versus standard of care alone (control arm), in mild Covid-19 patients with a positive SARS CoV-2 RT PCR test for COVID-19 and randomized within 5 days of onset of symptoms.

In April this year, Hetero had entered into a non-exclusive licensing agreement with MSD, to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs).

There were fewer hospital admissions in Molnupiravir group compared to standard of care alone over 14 days of observation, the interim results said.

"Phase 3 Trial Demonstrates Statistically Significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with Molnupiravir Treatment in mild COVID-19 patients compared to standard of care alone," Hetero said.

There was no mortality in either group and all adverse events were non-serious, mild in severity, and none led to drug discontinuation, the drug maker said.

Most common adverse events reported were nausea, diarrhoea and headache which were resolved completely, according to Hetero, which is also undertaking a separate Molnupiravir study on moderate Covid-19 patients approved by Central Drugs Standard Control Organisation, the company added.